Kornimate/medical-research-clean huggingface dataset:
evaluate the effect of omega-3 vs soy isoflavones in postmenopausal women with moderate to severe vasomotor symptoms

Conditions: Menopause; Hot Flashes

Summary: this study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women treated for 4 months with omega-3 vs soy isoflavones.

this is a non-inferiority study of omega 3 versus soy isoflavones, being each patient its own control from the baseline. in order to determine the difference observed in the evolution of intensity, frequency and the total number of hot flashes in 4 months in patients treated with omega-3 vs soy isoflavones, is planned to include at least 100 patients, 50 per treatment arm. it si estimated a standar deviation of 0.5%, and a 10% lost follow-up rate.

Eligibility criteria:
inclusion criteria: * ambulatory and can complete all study procedures, which are able to read, understand and sign an informed consent and willing to come to the center for study visits. * postmenopausal (≥ 1 year of amenorrhea) or 6 months or more of amenorrhea with follicle stimulating hormone (fsh) ≥ 40 iu / l. * bmi ≥ 18 kg/m2 and ≤ 30 kg/m2 * flushing of moderate to severe intensity. exclusion criteria: * women with surgical menopause. * treatment with hormone replacement therapy (hrt) in the 3 months prior to inclusion * uterine bleeding after menopause with undetermined cause in the 12 months prior to screening. * presence or history of malignancy in the past 5 years. * malabsorption syndrome. * hype or uncontrolled hypothyroidism. * dyslipidemia (ldl-cholesterol\> 189 mg / dl or medical criteria) requiring an specific treatment of proven effectiveness. * chronic renal disease. * uncontrolled or untreated hypertension. * treatment with isoflavones, tibolone, selective estrogen receptors moderators (serm´s) in the past 3 months prior to the testing selection period. * hormonal treatment with androgens, estrogens, progestins, alone or combined oral, transdermal, vaginal (including promestriene) or implant, in the last 3 months prior to testing selection period. * patients who receive or require treatment with antidepressants or anticonvulsants * patients with mental illness. * history of noncompliance with taking medication. * suspected or abuse of alcohol or other drugs during the 12 months preceding the selection. * use of any experimental drug or device within 30 days prior to the selection. * any other condition or finding that a judgment of the investigator may jeopardise the tral conduct according to the protocol.

Keywords: vasomotor symptoms associated with menopause menopause hot flashes postmenopausal women
a phase 1/2 study to assess multistem® therapy in acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: a study to examine the safety (and potential efficacy) of the adult stem cell investigational product, multistem, in adults who have acute respiratory distress syndrome (ards). the primary hypothesis is that multistem will be safe in ards patients.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe ards, as defined by the berlin definition, requiring an endotracheal or tracheal tube * able to receive investigational medicinal product within 96 hours of meeting the last of the ards diagnosis criterion exclusion criteria: * concurrent illness that shortens life expectancy to less than 6 months * other serious medical or psychiatric illness
tolerance and efficiency of paracetamol subcutaneous injection

Conditions: Pain

Summary: the purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous administration of paracetamol for patients in palliative care.

subcutaneous administration is the most commonly used way for palliative care and geriatric service. a lot of drugs are recommended with subcutaneous administration, but their use is performed out of the marketing authorization, and fewer data exist about this practice in literature. paracetamol is a grade 1 analgesic not currently recommended for subcutaneous injection, because of the lack of validated references. however this kind of administration is usually performed for paracetamol in the french palliative care services related with its advantages for patients, as analgesic or antipyretic. the assumption of the study is that the use of paracetamol subcutaneously is possible with a good tolerance for hospitalized patients in palliative care service.

Eligibility criteria:
inclusion criteria: * older than 18 years old * indication of paracetamol by subcutaneous injection, as an analgesic or an antipyretic exclusion criteria: * opposition to gather data patient * subcutaneous administration of paracetamol during the last week before the inclusion of the patient
sudden cardiac death in heart failure trial (scd-heft)

Conditions: Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Heart Failure, Congestive; Heart Failure

Summary: to compare conventional treatment of congestive heart failure (chf) with two experimental interventions: amiodarone and an implantable cardioverter-defibrillator (icd).

background: congestive heart failure is a major cause of mortality and morbidity, and sudden arrhythmic death is the cause of death in from 30 to 50 percent of those who die. the study addresses the problem and tests two interventions that have promise of benefit. to date, many of the therapies that have been tested for congestive heart failure have either been ineffective or actually decreased survival. conventional therapy is still relatively ineffective in that recent studies such as the congestive heart failure - survival trial of antiarrhythmic therapy (chf-stat) have demonstrated a mortality of 40 percent during two-and-half years of follow-up. the implantable cardioverter-defibrillator appears to be effective in patients who are resuscitated from cardiac arrest, but until recently, the devices required a thoracotomy and had to be reserved for patients with the highest risk for sudden death. the newer transvenous devices with pectoral patches can now be considered for broader applications. although there have been mixed results with amiodarone in patients with congestive heart failure, there is a general consensus that it could be effective in the proper subset of patients with congestive heart failure. a comparison of the optimal device and drug is appropriate for such a high risk population. design narrative: three-armed, randomized, multicenter trial conducted at over 125 north american, australian and new zealand sites. patients were enrolled over 2.5 years after being randomly assigned to amiodarone, matched placebo or an implantable cardiac defibrillator (icd). median follow-up was 45.5 months. all three arms used conventional therapy for heart failure and coronary artery disease (ace inhibitors, lipid lowering and beta-blockers). the central hypothesis was that amiodarone or the icd would improve survival compared to placebo. the primary outcome was the prevention of all-cause mortality. secondary outcome measures included cardiac mortality and arrhythmic mortality, morbidity, quality of life, and incremental cost-effectiveness of the interventions. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
patients with new york heart association class ii or class iii heart failure and ejection fraction less than or equal to 35%.
noninvasive positive pressure ventilation during neonatal nasal intubation

Conditions: Infant, Newborn, Diseases; Intubation Complication

Summary: the goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the department of neonatology of the university hospital zurich. the primary aims are: * successful nasal intubation at the first attempt without physiological instability. * comparison of infants with successful intubation at the first attempt without physiological instability to the infants in the shine-trial in australia. participants will be intubated according to our standard intubation procedure using non-invasive ventilation (niv) delivered through a nasopharyngeal tube.


Eligibility criteria:
inclusion criteria: * any neonate at the department of neonatology of the university hospital zurich undergoing endotracheal intubation in the delivery room or neonatal intensive care unit. exclusion criteria: * requirement for immediate endotracheal intubation as determined by the treating clinician, without time for potential application of nippv, e.g. active cardiopulmonary resuscitation. * contraindication to nippv use (e.g. congenital diaphragmatic hernia, abdominal wall defects). * oral intubation planned. * denial of parental consent and/or inability of the parents to understand the study procedures due to cognitive or linguistic reasons. * withdrawal at the discretion of the intubating clinician if he / she feels the study is interfering with a safe and optimal treatment of the patient.

Keywords: intubation non-invasive ventilation non-invasive positive pressure ventilation continuous positive airway pressure mechanical ventilation physiological stability
effects of intraovarian platelet rich plasma in women with poor ovarian response and premature ovarian insufficiency

Conditions: Premature Ovarian Failure; Diminished Ovarian Reserve

Summary: reproductive age women diagnosed with poor ovarian response (por) based on poseidon criteria and premature ovarian insufficiency (poi) based on eshre criteria and with a history of at least one prior failed ivf cycle will be recruited for the study. antral follicle count (afc), serum anti-mullerian hormone (amh), and early follicular phase serum follicle stimulating hormone (fsh) levels will determined at baseline. autologous blood obtained from peripheral vein will be used to prepare prp following standard protocols and will be injected to at least one ovary. ovarian reserve parameters and ivf outcomes will be determined.

reproductive age women diagnosed with por based on poseidon criteria and poi based on european society of human reproduction and endocrinology (eshre) criteria with a history of at least one prior failed ivf cycle will recruited for the study. antral follicle count (afc), serum anti-mullerian hormone (amh), and early follicular phase serum follicle stimulating hormone (fsh) levels will be determined at baseline. autologous blood obtained from peripheral vein will be used to prepare prp following standard protocols. prp injection will be performed under sedation anesthesia, using a 35 cm 17 g needle under transvaginal ultrasound guidance. on the 2-4th days of the first six menstrual cycles following the procedure, afc, amh, and fsh levels will be re-assessed. patients with at least one antral follicle will be started on ovarian stimulation for in-vitro fertilization- intracytoplasmic sperm injection (ivf-icsi), followed by embryo banking/ preimplantation genetic testing- aneuploidy (pgt-a) or embryo transfer. markers of ovarian reserve (afc, fsh, amh), and ivf laboratory outcome parameters (number of metaphase ii (mii) oocytes, 2pn(pronucleus) embryos, cleavage stage, blastocyst embryos) will be followed.

Eligibility criteria:
inclusion criteria: * patients with a history of \>1 year infertility duration with at least one ovary, who fulfilled the eshre criteria, * patients diagnosed with por based on poseidon criteria and with a history of at least one prior failed ivf cycle exclusion criteria: * presence of pregnancy, * previous diagnosis of any malignancy, * ovarian insufficiency secondary to sex chromosome etiology, * prior major lower abdominal surgery resulting in pelvic adhesions, * anticoagulant use for which plasma infusion is contraindicated, * current or previous (immunoglobulin a (iga) deficiency
safety and effectiveness of the peripheral balloon-expandable covered stent system for iliac artery stenosis/occlusion. (select)

Conditions: Peripheral Artery Disease (PAD)

Summary: this is a prospective, multi-center, single-arm clinical trial to evaluate the peripheral balloon-expandable covered stent system for treating stenosis and/or occlusion in the common and external iliac arteries. the safety and effectiveness of the stent system will be compared to pre-set performance goals. all treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.


Eligibility criteria:
inclusion criteria: * participants aged 18 to 80 years, regardless of sex; * participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery; * participants with a rutherford classification of 2 to 4 for the target limb; * participants or their legal representatives must be able to understand the study's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form. exclusion criteria: * pregnant or planning to become pregnant, or breastfeeding women; * participants who have previously had a vascular graft implanted in the native iliac artery; * participants who have had a stroke or myocardial infarction within 3 months prior to enrollment; * participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (pt or aptt ≥ 2 times the upper limit of normal; or platelet count \&lt; 80×10\^9/l); * participants with serum creatinine ≥ 221 μmol/l (2.5 mg/dl) or currently undergoing dialysis; * alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 2 times the upper limit of normal; * severe anemia (hemoglobin level \&lt; 60.0 g/l); * participants known to be allergic or intolerant to cobalt-based alloys, expanded polytetrafluoroethylene (eptfe), aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or other study materials and medications; * participants who have undergone vascular intervention within 30 days prior to surgery or who plan to undergo vascular intervention within 30 days following surgery; * participants who have received intra-arterial thrombolysis treatment in the target vessel within 14 days prior to enrollment; * participants with significant organ dysfunction or other severe conditions that may lead to non-compliance with the study protocol, affect data interpretation, or have a life expectancy insufficient to complete the clinical trial; * participants currently involved in a clinical trial of investigational drugs, biologics, or medical devices; * other conditions that, in the investigator's opinion, make the participant unsuitable for the clinical trial.

Keywords: covered stent iliac artery
venous ultrasound guided organ decongestion in patients hospitalized with acute decompensated heart failure

Conditions: Cardiorenal Syndrome; Heart Failure; Acute Kidney Injury; Acute Decompensated Heart Failure

Summary: the purpose of this study is to assess the feasibility, safety and effectiveness of vexus guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (adhf). 180 patients will be randomly assigned to either intervention (vexus) arm or standard of care (soc) arm. in the intervention arm, the treatment team will be informed by the study team about the results of the vexus examination to supplement the clinical decision of proper decongestion treatment, while no information will be provided in the standard of care arm. study visits are scheduled every second day while hospitalized, end of study is set to day of discharge from the ward. telephone consultation and review of medical journal scheduled after 6 months to assess exploratory endpoints. the overall rationale of the the study is to investigate if venous organ congestion investigated by vexus score, is a modifiable risk factor in patients hospitalized with adhf. and secondary to assess if venous organ decongestion guided by vexus score may safely be implemented in patients hospitalized with adhf and result in: * differences in length of hospitalization * changes in biomarkers of cardiac strain * changes in renal function and markers of renal injury * achieved doses of heart failure treatment at discharge * in-hospital complications safety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.


Eligibility criteria:
inclusion criteria: * 18 years of age or above * admitted the ward of department of cardiology ouh ullevål with a clinical diagnosis of adhfdefined by european society of cardiology * pro-bnp \> 800 ng/l at first day of admission * capable of giving signed informed consent exclusion criteria: - any medical or psychiatric condition which in the opinion of the investigatorprecludes participation

Keywords: cardiorenal syndrome acute kidney injury heart failure vexus venous congestion
clinical evaluation of the truenat point-of-care tuberculosis diagnostic test

Conditions: Tuberculosis, Pulmonary

Summary: consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. in the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.


Eligibility criteria:
inclusion criteria: case detection group: * age 18 years or above * clinical suspicion of pulmonary tb (including cough ≥2 week and at least 1 other symptom typical of tb); * willingness to provide 3-4 sputum specimens at enrolment; * willingness to have a trial follow-up visit approximately 2 months after enrolment; * provision of informed consent. drug resistant tb group: in addition to the criteria of the case detection group, participants should also meet the following conditions: * non-converting pulmonary tb cases (category i and category ii failures) exclusion criteria: case detection group: * receipt of any dose of tb treatment within 60 days prior to enrolment (even if within last two days only). drug resistant tb group: * receipt of any dose of mdr-tb treatment within 60 days prior to enrolment (even if within last two days only).
dapagliflozin on outcomes of rhythm control strategy (pharmacological ± interventional) in patient with atrial fibrillation

Conditions: Dapagliflozin (Forxiga); Atrial Fibrillation (AF)

Summary: investigator study the efficacy and safety outcomes of dapagliflozin use among newly diagnosed atrial fibrillation patients when underwent rhythm control strategy regardless their diabetic status.

atrial fibrillation (af) is the most common arrhythmia among adults with increasing risk of stroke, heart failure (hf) and mortality . based on the east-afnet 4 trial and nationwide cohort studies, early rhythm control treatment (antiarrhythmic drugs aad or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation a new oral hypoglycemic drug, dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (sglt2i), was confirmed to reduce the risk of cardiovascular adverse events (aes) and improve coronary heart disease and hf outcomes in multiple clinical trials . in addition, previous post hoc analyses and meta-analyses reported that dapagliflozin can decrease the incidence rate of new-onset af recent trials and meta-analyses have reported that sglt2i can achieve greater suppression of af recurrence after catheter ablation (ca) in t2dm patients . nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of af among newly diagnosed af patients who underwent rhythm control strategy regardless the diabetic status.

Eligibility criteria:
inclusion criteria: * newly diagnosed af patients (time between af diagnosis to rhythm control attempt less than one year) paroxysmal and persistent atrial fibrillation (af) documented on a 12 lead ecg, holter monitor (episodes of af must be \>30 seconds in duration to qualify as an inclusion criterion) age of 18 years or older on the date of consent. informed consent exclusion criteria: * long standing persistent af. previous use of dapagliflozin within one month of rhythm control attempt. previous rhythm control attempt. af due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery). history of congestive heart failure. active intracardiac thrombus pre-existing pulmonary vein stenosis or pulmonary vein stent contraindication to anticoagulation or radio contrast materials

Keywords: dapagliflozin rythme control
the comparison between ringer lactate solution and normal saline with dextrose water in post-operative period of kidney transplantation

Conditions: Electrolyte Imbalance; Kidney Transplant; Complications

Summary: this is a randomized controlled pragmatic clinical trial. we aim to evaluate the effect of ringer lactate solution (rls) and normal saline solution (nss) with dextrose water (d5w) on the electrolyte abnormality of kidney transplant recipients (ktr) during the first post-operative week. the problem with using nss with or without d5w as a standard replacement fluid is the hyperchloremic metabolic acidosis which might compromise the kidney allograft function. a total 60 ktr will be enrolled and randomized to receive either rls or nss with d5w. the primary outcome is serum bicarbonate level at day 5 after transplantation. secondary outcomes include the serum potassium, serum sodium, serum chloride, cytokine panel, and the incidence of delayed graft function.


Eligibility criteria:
inclusion criteria: * a kidney transplant recipient who receives transplant at king chulalongkorn memorial hospital. * age \>=18 years * both deceased donor and living donor kidney transplantation will be included exclusion criteria: * multiorgan transplantation * known allergy to rls or nss
lifestyle changes in fatty liver; additive effect of honey intake

Conditions: Fatty Liver, Nonalcoholic

Summary: honey is a natural functional food used in control cardiovascular risk factors but its effect on fatty liver is not investigated

forty fatty liver (non-alcoholic from) patients with obesity are included to be divided into group 1 who will contain 20 patients who will receive honey intake (orally, as a daily total dose of 2 g/kg, this dose will be divided to three equal subdoses, every dose will be administered before meal), low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks. group 2 who will contain 20 patients who will receive low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks.

Eligibility criteria:
inclusion criteria: * fatty liver (non alcoholic form) * both sexes included * obese subjects (class i) exclusion criteria: * cardiac insult * respiratory insult * renal insult * lower limb insult